Myocardial Needle Temperature Probe

GUDID B040XE21252T

Myocardial Needle Temperature Probe

GENESEE BIOMEDICAL, INC.

General-purpose patient temperature probe, single-use
Primary Device IDB040XE21252T
NIH Device Record Key375225cc-591e-4812-a10a-46def57e2742
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyocardial Needle Temperature Probe
Version Model NumberXE2125
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 786-4890
Emailinfo@geneseebiomedical.com
Phone800 786-4890
Emailinfo@geneseebiomedical.com

Device Dimensions

Length44 Millimeter
Length44 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040XE21251 [Primary]
HIBCCB040XE21252T [Package]
Contains: B040XE21251
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-01

On-Brand Devices [Myocardial Needle Temperature Probe]

B040XE24252WMyocardial Needle Temperature Probe
B040XE21262UMyocardial Needle Temperature Probe
B040XE21252TMyocardial Needle Temperature Probe
B04024262TMyocardial Needle Temperature Probe
B04024242RMyocardial Needle Temperature Probe
B04024232QMyocardial Needle Temperature Probe
B04021242OMyocardial Needle Temperature Probe
B04021232NMyocardial Needle Temperature Probe

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